BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET

    MDR report key: 20662075 · Received November 12, 2024

    Report

    Report Number
    20662075
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    July 19, 2024
    Report Date
    October 3, 2024
    Manufacturer
    SMITH NEPHEW MEDICAL LIMITED
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A WOUND DEBRIDEMENT IN SURGERY, THE 3 LITER BAG AND TUBING WAS CONNECTED TO THE VERSAJET AND WHEN THE PHYSICIAN TRIED TO USE THE DEVICE IT POPPED APART. THE DEVICE WAS REMOVED, A NEW DEVICE OBTAINED AND THE SURGERY CONTINUED WITHOUT INCIDENT, NO HARM TO THE PATIENT. THE DEVICE WAS GIVEN TO SUPPLY CHAIN TO REACH OUT TO THE MANUFACTURER REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975494 VERSAJET LAVAGE, JET FQH SMITH NEPHEW MEDICAL LIMITED 66800041 (10)51222713

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown